Clinical Trial in Females With Female Pattern Hair Loss

Launched by JOHNSON & JOHNSON HEALTHCARE PRODUCTS DIVISION OF MCNEIL-PPC, INC. · Jun 15, 2010

Keywords

ClinConnect Summary

This is a phase 3, two-arm, randomized, active-controlled, multi-center, 52-week, parallel design trial to evaluate the efficacy and safety in women with Female Pattern Hair Loss (FPHL), comparing the new 5% minoxidil topical foam (MTF) formulation versus the 2% minoxidil topical solution (MTS) formulation.

This clinical trial is designed to compare the risk/benefit profile of the 5% MTF formulation applied once a day versus the 2% MTS applied twice a day (BID), using objective efficacy measures and safety assessments.

Study centers will screen a sufficient number of participants so that ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • females, age 18 or older in general good health
• • exhibits female pattern hair loss
• • signs and dates an informed consent document
• • agrees to use an adequate method of birth control; if of childbearing potential
• • shows a negative urine pregnancy test at Screening Visit
• • is willing to maintain the same hair style, hair color, and hair regimen throughout the study
• • is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
• Exclusion Criteria:
• • hypersensitivity to the study product, or any ingredients of the study product
• • known allergy to hair dye, or hair dye components
• • clinically relevant history of hypotension
• • untreated or uncontrolled hypertension
• • pregnant, planning a pregnancy or nursing a child
• • history of hair transplants
• • currently use hair weaves or non-breathable wigs
• • dermatologic disorders of the scalp that require chronic use of medication for control
• • other types or history of hair loss
• • enrolled in any other investigational medication (drug) study currently, or within the last 6 months